Featured Publications
The Critical Shortage of Iodinated Contrast Material — Will Value Prevail?
Tu LH, Miller JE, Forman HP. The Critical Shortage of Iodinated Contrast Material — Will Value Prevail? New England Journal Of Medicine 2022, 387: 491-493. PMID: 35704416, DOI: 10.1056/nejmp2206996.Peer-Reviewed Original ResearchAccess to COVID-19 Vaccines in High-, Middle-, and Low-Income Countries Hosting Clinical Trials
Ramachandran R, Ross JS, Miller JE. Access to COVID-19 Vaccines in High-, Middle-, and Low-Income Countries Hosting Clinical Trials. JAMA Network Open 2021, 4: e2134233. PMID: 34792596, PMCID: PMC8603077, DOI: 10.1001/jamanetworkopen.2021.34233.Peer-Reviewed Original ResearchEvaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs
Miller JE, Mello MM, Wallach JD, Gudbranson EM, Bohlig B, Ross JS, Gross CP, Bach PB. Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs. JAMA Network Open 2021, 4: e217075. PMID: 33950209, PMCID: PMC8100865, DOI: 10.1001/jamanetworkopen.2021.7075.Peer-Reviewed Original ResearchConceptsFDA approvalHigh-income countriesDrug approvalIncome countriesNovel drugsDrug Administration (FDA) drug approvalsRegulatory agency websitesCross-sectional analysisProportion of drugPrimary outcomeFDA drug approvalsProportion of countriesDrug trialsMAIN OUTCOMEUS FoodClinical researchCountry income levelLow-income countriesMarketing approvalTrialsGoogle ScholarDrugsDrug companiesApprovalMedian
2023
Transparency of Results Reporting in Cancer Clinical Trials
Kao J, Ross J, Miller J. Transparency of Results Reporting in Cancer Clinical Trials. JAMA Network Open 2023, 6: e2328117. PMID: 37556143, PMCID: PMC10413165, DOI: 10.1001/jamanetworkopen.2023.28117.Peer-Reviewed Original ResearchClinical Trial Diversity—Will We Know It When We See It?
Varma T, Gross C, Miller J. Clinical Trial Diversity—Will We Know It When We See It? JAMA Oncology 2023, 9: 765-767. PMID: 37022678, DOI: 10.1001/jamaoncol.2023.0143.Peer-Reviewed Original ResearchWhat is Fair Representation in Research?
Miller J, Latham S. What is Fair Representation in Research? The American Journal Of Bioethics 2023, 23: 89-91. PMID: 37220359, DOI: 10.1080/15265161.2023.2201543.Peer-Reviewed Original ResearchRanking pharmaceutical companies on clinical trial diversity
Varma T, Miller J. Ranking pharmaceutical companies on clinical trial diversity. The BMJ 2023, 380: p334. PMID: 36764687, DOI: 10.1136/bmj.p334.Peer-Reviewed Original Research
2022
Drug repurposing: a systematic review on root causes, barriers and facilitators
Krishnamurthy N, Grimshaw AA, Axson SA, Choe SH, Miller JE. Drug repurposing: a systematic review on root causes, barriers and facilitators. BMC Health Services Research 2022, 22: 970. PMID: 35906687, PMCID: PMC9336118, DOI: 10.1186/s12913-022-08272-z.Peer-Reviewed Original ResearchConceptsData accessIntellectual property challengesDesign decisionsCompound databasesExamples of companiesBusiness reasonsCore approachRoot causeMulti-partner collaborationsText termsFull potentialText reviewBusiness Source CompleteResourcesAccessCollaborationDatabaseSuperiorityMore informationSafety problemsDiversity in clinical research: public health and social justice imperatives
Varma T, Jones CP, Oladele C, Miller J. Diversity in clinical research: public health and social justice imperatives. Journal Of Medical Ethics 2022, 49: 200-203. PMID: 35428737, DOI: 10.1136/medethics-2021-108068.Peer-Reviewed Original Research
2021
Implementation of 21st Century Cures Act Expanded Access Policies Requirements
Kang S, Chang S, Ross JS, Miller JE. Implementation of 21st Century Cures Act Expanded Access Policies Requirements. Clinical Pharmacology & Therapeutics 2021, 110: 1579-1584. PMID: 34431083, DOI: 10.1002/cpt.2401.Peer-Reviewed Original ResearchClinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis
Axson S, Mello MM, Lincow D, Yang C, Gross C, Ross JS, Miller J. Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis. BMJ Open 2021, 11: e053248. PMID: 34281933, PMCID: PMC8291313, DOI: 10.1136/bmjopen-2021-053248.Peer-Reviewed Original ResearchDirect-to-consumer personal genomic tests need better regulation
Moneer O, Miller JE, Shah ND, Ross JS. Direct-to-consumer personal genomic tests need better regulation. Nature Medicine 2021, 27: 940-943. PMID: 34017136, DOI: 10.1038/s41591-021-01368-9.Commentaries, Editorials and Letters2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics
Benjamin IJ, Valentine CM, Oetgen WJ, Sheehan KA, Brindis RG, Roach WH, Harrington RA, Levine GN, Redberg RF, Broccolo BM, Hernandez AF, Douglas PS, Piña IL, Benjamin EJ, Coylewright MJ, Saucedo JF, Ferdinand KC, Hayes SN, Poppas A, Furie KL, Mehta LS, Erwin JP, Mieres JH, Murphy DJ, Weissman G, West CP, Lawrence WE, Masoudi FA, Jones CP, Matlock DD, Miller JE, Spertus JA, Todman L, Biga C, Chazal RA, Creager MA, Fry ET, Mack MJ, Yancy CW, Anderson RE. 2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics. Circulation 2021, 143: e1035-e1087. PMID: 33974449, DOI: 10.1161/cir.0000000000000963.Peer-Reviewed Original ResearchReporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics
Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Network Open 2021, 4: e217063. PMID: 33877309, PMCID: PMC8058642, DOI: 10.1001/jamanetworkopen.2021.7063.Peer-Reviewed Original ResearchConceptsNovel cancer therapeuticsPostmarketing studyBlack patientsCancer therapeuticsDemographic dataOlder adultsUS cancer populationUS Cancer StatisticsCross-sectional studyRace/ethnicityParticipants' demographic characteristicsPercentage of trialsPatient sexCancer populationClinical studiesCancer statisticsMAIN OUTCOMEDrug AdministrationFDA approvalStudy participantsCancer typesDemographic characteristicsDemographic informationStudy samplePatientsEquitable Access to Research Benefits: Considerations for COVID-19 Vaccine Development and Clinical Trial Crossover
Zaidi D, Miller J, Varma T, Boatright D, Friesen P. Equitable Access to Research Benefits: Considerations for COVID-19 Vaccine Development and Clinical Trial Crossover. The American Journal Of Bioethics 2021, 21: 86-88. PMID: 33616486, DOI: 10.1080/15265161.2020.1870768.Peer-Reviewed Original ResearchCOVID-19 vaccine research and the trouble with clinical equipoise
Friesen P, Caplan AL, Miller JE. COVID-19 vaccine research and the trouble with clinical equipoise. The Lancet 2021, 397: 576. PMID: 33539728, PMCID: PMC7906638, DOI: 10.1016/s0140-6736(21)00198-7.Peer-Reviewed Original Research
2019
Managing conflicts of interest in pharmacy and therapeutics committees: A proposal for multicentre formulary development
Friesen P, Caplan AL, Miller JE. Managing conflicts of interest in pharmacy and therapeutics committees: A proposal for multicentre formulary development. Journal Of Clinical Pharmacy And Therapeutics 2019, 45: 249-255. PMID: 31657022, DOI: 10.1111/jcpt.13067.Peer-Reviewed Original ResearchSharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
Miller J, Ross JS, Wilenzick M, Mello MM. Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices. The BMJ 2019, 366: l4217. PMID: 31292127, PMCID: PMC6614834, DOI: 10.1136/bmj.l4217.Peer-Reviewed Original ResearchConceptsClinical trial dataTrial dataDrug approvalSectional descriptive studyPharmaceutical companiesFDA drug approvalsLarge pharmaceutical companiesClinical trialsDrug levelsNew drug approvalsUS FoodDrug AdministrationNew drug applicationsFDA approvalPatientsNovel drugsDescriptive studyDrug applicationTrialsDrugsExternal investigatorsSharing scoreDrug companiesTrial transparencyStudy measuresPostmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis
Wallach JD, Luxkaranayagam AT, Dhruva SS, Miller JE, Ross JS. Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis. BMC Medicine 2019, 17: 117. PMID: 31203816, PMCID: PMC6572730, DOI: 10.1186/s12916-019-1344-3.Peer-Reviewed Original ResearchConceptsNew clinical trialsClinical trialsPostmarketing commitmentFDA approvalPeer-reviewed journalsNovel drugsPharmaceutical companiesCross-sectional analysisRate of completionRates of registrationClinical studiesPublic reporting requirementsFirst approvalTherapeutic evaluationUS FoodDrug AdministrationTrialsNew drugsFDA documentsBiologicsFDADrugsFDA recordsApprovalStatus
2018
Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
Zou CX, Becker JE, Phillips AT, Garritano JM, Krumholz HM, Miller JE, Ross JS. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study. Trials 2018, 19: 581. PMID: 30352601, PMCID: PMC6199729, DOI: 10.1186/s13063-018-2957-0.Peer-Reviewed Original ResearchConceptsRetrospective cohort studyPublication biasNeuropsychiatric indicationsCohort studyClinical trialsRelative riskEfficacy trialsFDA approvalPositive trialsFisher's exact testRecent FDA approvalDrug Administration Amendments ActClinical trial publicationsTRIAL REGISTRATIONMAIN OUTCOMEProportion of trialsNeuropsychiatric drugsNew drug approvalsTrial publicationsExact testMedical interventionsTrialsDrug approvalNew drugsDrugs